JPRN-jRCTs021190001RecruitingPhase 4
Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients - TJ116E
Ishii Tadashi0 sites24 target enrollmentStarted: May 8, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. Patients waiting for chest upper to lower
- •esophageal cancer radical resection
- •2. Pre treatment cStage:II, III, IVA (except for T4b, N3) TNM classification:T=1-4a, N=0-2, M=0(TNM-UICC 8 th edition)
- •3. Performance Status:0-2
- •4. Hospital Anxiety and Depression Scale (HADS): 8 <=
- •5. 20 years old and over
- •6. Medical examination classification:outpatient and inpatient
- •7. Patients who obtain document consent from the principal
Exclusion Criteria
- •1. Patients who have past history of abdominal surgery
- •2 Patients who have past history of ileus
- •3 Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease
- •4. Eemergent surgery
- •5. Patients who took prohibited concomitant drugs 4 weeks before treatment
- •6. Patients who have past history of radiotherapy and radiation chemotherapy for esophageal cancer
- •7. Patients who have past history of allergy for other Kampo formulation(s) or lactose intolerance
- •8. Patients who have serious concomitant diseases
- •9. A woman who is pregnant, has a possibility of pregnancy, is within 28 days after birth, is breastfeeding
- •10. Dementia patients
- •11. Others, including patients who are unfit for the study as determined by the attending physician
Investigators
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